510(k) Report

Devices descending from K925699

468 later devices reach Harmonic Scalpel Laparosonic Clamp Coagulator Acc. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+8K101042BladeviewAccogent, LLC20100—
+8K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+9K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+9K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+9K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+9K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+9K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+9K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+9K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+9K243884TavipilotCaranx Medical20250—
+9K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+9K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+9K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+9K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+9K233230See Factor CT3™Epica International, Inc.20240—
+9K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+9K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+9K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+9K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+9K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+9K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+9K223550DMXDel Medical, Inc.20230—
+9K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+9K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+9K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—
+9K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+9K213479D²RS and D²RS 9090Stephanix20211—
+9K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+9K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+9K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+9K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+9K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+9K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+9K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+9K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+9K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+9K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+9K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+9K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+9K200887AS-10Canon, Inc.20200—
+9K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+9K192877Senhance Surgical SystemTransenterix, Inc.20197—
+9K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+9K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+9K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+9K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+9K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+9K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+9K180651Uroview FD IIPausch Medical GmbH20180—
+9K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+9K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+9K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+9K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+9K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+9K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+9K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+9K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+9K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+9K151904SyncVision SystemVolcano Corporation201521
+9K151485GenesisDornier Medtech America, Inc.20151—
+9K133434Genesis IIDornier Medtech America, Inc.20142—
+9K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+10K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+10K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+10K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+10K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+10K252503Intelligent NRCanon, Inc.20260—
+10K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+10K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+10K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+10K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+10K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+10K2434463DXRGE Medical Systems SCS20250—
+10K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+10K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+10K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+10K233543YSIO X.preeSiemens Medical Solutions20241—
+10K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+10K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+10K231995AcuityUDRRadmedix, LLC20230—
+10K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+10K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+10K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+10K222240Explorer Air® IISurgvision GmbH20231—
+10K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+10K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+10K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+10K221217SPY LaparoscopeStryker20221—
+10K221335D²RS and D²RS 9090Stephanix20220—
+10K220871NautilusDornier Medtech America, Inc.20220—
+10K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+10K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+10K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+10K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+10K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111